108 Regulatory Submissions Jobs

You will be responsible for providing highly advanced expert support and functional and technical leadership to ensure the scientific integrity and validity for clinical development, early development, and/or research projects. Your main tasks will include developing and applying biostatistics and programming methods to ensure valid conclusions, as well as providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. Additionally, you may also provide statistical support to research or other R&D areas. To meet challenges in data review, big data, analytics, and reporting of clinical trial data, you may independently provide timely and professional leadership of special projects that focus on innovative tools and systems. You will strategically and tactically support the Director Clinical Data Standards and be responsible for advising/leading the planning, development, and implementation of Industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. Your role will also involve providing expert support and stellar customer focus to business users and teams on their use of data standard collection tools, data transfer specifications, analysis data/TFL standards/Define, automation solutions/technologies, and business infrastructure, business rules, and guidelines. You may also lead global teams as required. At the study level, you will be responsible for all statistical tasks on assigned clinical or non-clinical trials, particularly for high complexity trials, seeking peer input/review as required. You will contribute to protocol development, statistical analysis plan development, and reporting activities. Additionally, you will provide statistical expertise to support submission activities and documents, meetings with Health Authorities, pricing agencies, and other drug development activities. You will independently lead interactions with external review boards/ethics committees, external consultants, and represent the organization in statistical discussions at external congresses, conferences, and scientific meetings. You will be responsible for strategic statistical input into one or more projects, collaborating with clinical, regulatory, and other strategic functions to drive quantitative decision-making in drug development. At the disease area/TA/indication level, you will drive strategic statistical input and excellence to development programs within the assigned areas. Additionally, you may lead or significantly contribute to initiatives at the global line function level or cross-functional franchise level, requiring coordination of diverse team members. You will actively contribute to cross-functional organizational/process/scientific consulting improvement initiatives and represent the organization in due diligence teams for in-licensing opportunities. The ideal candidate will have an MS (in Statistics or equivalent) with 10+ years of relevant work experience or a PhD with 6+ years of relevant work experience. Strong interpersonal and communication skills, along with proven expertise in statistics and its application to clinical trials, are essential. Additionally, experience with statistical software packages such as SAS or R, and a strong understanding of drug development and Health Authority guidelines are required. The role may also require expertise in pharmacokinetics, exposure-response modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Novartis is committed to providing reasonable accommodation to individuals with disabilities. For more information or to request accommodation during the recruitment process, please contact [email protected] and include the job requisition number in your message.,

The role of General Manager, Veterinary Sciences at Syngene International Ltd. in Bangalore is a highly strategic position responsible for leading the BBRCs in vivo research operations. As the Head of Veterinary Sciences, you will oversee a 50,000 sq. ft. AAALAC-accredited facility supporting various therapeutic and functional areas. Reporting to BMS Veterinary Sciences leadership and the Head of Site Operations, you will play a crucial role in the BBRC Operations Leadership Team. Your main responsibilities will include ensuring high-quality support for in vivo pharmacology, DMPK, toxicology, and translational research within the Veterinary Sciences BBRC function. You will collaborate with global stakeholders to align strategies across R&D sites and drive long-term strategies to develop capabilities and capacity in support of BMS drug discovery portfolio. As a leader, you will be responsible for coaching and developing a multidisciplinary team to meet departmental objectives while fostering a culture of excellence, collaboration, accountability, and continuous learning. Oversight of local aspects of veterinary care, animal welfare, and vivarium operations to ensure compliance with international regulations and BMS standards will also be part of your role. Your qualifications should include a PhD in Veterinary Science (a plus), board certification in Laboratory Animal Medicine, eligibility for veterinary licensure in India, and at least 15 years of experience in laboratory animal medicine with leadership roles in pharmaceutical or research settings. Additionally, you should have expertise across multiple species used in pharmaceutical research, strategic acumen in managing vivarium and veterinary functions, strong interpersonal and communication skills, and the ability to manage multiple projects with resilience and emotional intelligence. Preferred attributes for this role include operational leadership of multi-site or global veterinary functions, scientific innovation in developing in vivo disease models, and a passion for ethical research, leadership, and high-performing team development. Syngene International Ltd. is an equal opportunity employer committed to fostering a diverse and inclusive workplace.,

As a Manager of Biostatistics at Syneos Health, you will play a crucial role in ensuring that the Biostatistics department meets project timelines, delivers high-quality results, adheres to project requirements and SOPs, and operates within budget constraints. Your responsibilities will include participating in the development of department SOPs, overseeing staff development and training, promoting standardized processes, and facilitating succession planning. You will be responsible for setting goals for direct reports, managing their performance, identifying training needs, supporting development plans, mentoring, and coaching staff members. By actively participating in hiring, onboarding, transferring, and terminating staff, you will maintain a diverse team with the necessary skills and competencies to fulfill the department's business objectives. In addition to maintaining a good understanding of clinical drug development, regulatory guidelines, and biostatistics, you will provide mentorship within the Biostatistics department and conduct training for associates. Your role will involve prioritizing activities across projects, resolving project conflicts, assigning Biostatisticians to projects, conducting senior reviews of project deliverables, and leading or participating in multiple studies or programs. Furthermore, you may support business development activities, lead departmental or corporate initiatives, and undertake other work-related duties as assigned. Travel requirements for this role are minimal. To qualify for this position, you should hold a graduate degree in biostatistics or a related discipline and possess extensive experience in clinical trials or a relevant field. Previous management experience or demonstrated leadership abilities are preferred. A solid understanding of the drug development process, regulatory requirements, and relevant guidelines is essential, along with proficiency in English communication. Excellent interpersonal skills, including communication, presentation, and influencing abilities, are also required. At Syneos Health, we are dedicated to developing our employees, fostering a supportive and inclusive work culture, and creating a diverse and collaborative environment. Join us in our mission to accelerate customer success and make a meaningful impact in the biopharmaceutical industry. Please note that the tasks, duties, and responsibilities outlined in this job description may not be exhaustive. The Company reserves the right to assign additional tasks or responsibilities at its discretion. Qualifications may vary based on equivalent experience, skills, and education. This job description does not constitute an employment contract and is intended to comply with all applicable laws and regulations governing employment practices.,

Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to R&D staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What youd gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Masters or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.

Role & responsibilities Review of post approval changes and evaluating its impact on the products. Preparation of appropriate post approval submissions such as PAS, CBE 30 & 0, and annual reports. Management of product life cycle. Managing Team Dosage Form : Solid Oral / Nasal / Liquid/ Ophthalmics Preferred candidate profile 10+ Years of USFDA post approval submission experience USFDA Experience Exposure to ANDA /NDA post approval submissions Please share updated CV on hr19@hectorandstreak.com

As a Regulatory Affairs Specialist, you will play a crucial role in supporting the product lifecycle through obsolescence. Your responsibilities will include assessing changes made to the device post-launch to determine the regulatory impact of these changes on current clearance. You will ensure regulatory compliance by conducting thorough assessments and submitting the necessary documentation for product clearances and approvals from regulatory bodies such as the FDA and Notified Bodies. In this role, you will support new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based on regulatory changes. You will be seen as a valuable resource within the regulatory team, working with minimum supervision but keeping senior staff informed of your progress. Your tasks will involve developing and applying a basic understanding of regulatory frameworks, requirements, legislation, processes, and procedures. You will manage projects, write reports, coordinate regulatory activities, and execute regulatory assignments that are broad in nature. Additionally, you will assist in the development and review of standard operating procedures (SOPs) and contribute to regulatory strategy updates. You will provide regulatory input for new product development and product lifecycle planning, evaluate the regulatory impact of proposed changes to launched products, and investigate the regulatory history and background related to specific classes, diseases, therapeutics, or diagnostics for regulatory assessment. Your role will also involve determining and communicating submission and approval requirements to relevant stakeholders. To qualify for this position, you must have a Bachelor's or Master's degree in Regulatory Affairs, Engineering, or a related discipline. A minimum of 3-5 years of experience in a similar role within an R&D environment is preferred. Experience with post-market activities and change management will be advantageous, and holding an RAC Certification is also preferred. If you are looking to join a dynamic team where you can leverage your regulatory expertise to drive compliance and contribute to the successful launch of new products, this role may be the perfect fit for you. Apply now and be part of a team that is dedicated to ensuring regulatory excellence and innovation in the medical device industry.,

About Us: InSilicoMinds is a leader in the application of computational modeling and simulation (CM&S) for pharmaceutical research and development. We focus on harnessing cutting-edge in silico technologies to streamline drug design, formulation development, and regulatory submissions. Our innovative approaches help to accelerate drug discovery while optimizing formulations and ensuring high-quality manufacturing processes. Position Overview: We are looking for a highly skilled and motivated Computational Chemistry Expert with hands-on experience in retrosynthesis and reaction simulation. The ideal candidate will have deep expertise in computational chemistry tools and software, with a focus on optimizing reaction pathways to achieve high yields, minimal impurities, and selective production of specific isomers and polymorphs. Key Responsibilities: Lead retrosynthesis projects aimed at developing efficient synthetic routes for pharmaceutical compounds. Simulate reaction pathways and optimize reaction conditions, including solvent selection, temperature, and reagent concentrations, to maximize desired product yield. Address challenges related to regioselectivity, stereoselectivity, and polymorphism, ensuring the selective formation of specific isomers and crystalline forms. Collaborate with cross-functional teams, including synthetic chemists and formulators, to translate computational insights into experimental protocols. Utilize advanced computational chemistry tools and software to predict reaction outcomes, impurity formation, and scalability of processes. Continuously explore new computational methodologies and contribute to the development of in silico tools and workflows within the organization. Present and defend findings and strategies in project meetings, contributing to decision-making processes. Qualifications: Ph.D./ masters in computational chemistry, Organic Chemistry, or a related field, with strong knowledge of retrosynthesis and reaction mechanism modeling. Proven experience in simulating chemical reactions and optimizing reaction parameters to improve yield, reduce impurities, and control isomer or polymorph formation. Proficiency in computational chemistry software, such as Gaussian, Schrdinger, ORCA, or similar tools. Familiarity with molecular modeling techniques, including quantum chemistry, molecular dynamics, and thermodynamic simulations. Strong analytical skills and problem-solving abilities with attention to detail. Excellent communication skills and ability to work in a collaborative, interdisciplinary team environment. Preferred Experience: Experience with cheminformatics tools and databases for reaction prediction. Knowledge of AI or machine learning applications in retrosynthesis or reaction optimization. Experience in the pharmaceutical or chemical industry, especially in synthetic route design or process optimization.,

Prepare, compile & submit dossiers for product registration, variations & renewals to regulatory authorities.Ensure compliance with current regulations, guidelines & standards for pharmaceutical products.Knowledge of CTD/ACTD format is must.

Role & responsibilities Job Title: International Regulatory Affairs (IRA) Sr. Manager Location: Ahmedabad -HO Markets: CIS (Including EAEU), LATAM (Central and South America), Middle East, Africa, South East Asia. Key Responsibilities: 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 4. Liaise with regulatory authorities including (EU, CIS, LATAM, ROW, Asia) and others. 5.Develop and implement regulatory strategies across international markets (EU, CIS, LATAM, ROW, Asia, Middle East, and Georgia) to ensure timely submissions and approvals for product registrations and lifecycle maintenance. 6. Lead the preparation, review, and submission of CTD/eCTD/ACTD dossiers for multiple dosage forms including solid orals, injectables, topicals, and liquids for pharmaceutical and nutraceutical products, as per country-specific guidelines. 7.Manage lifecycle regulatory activities such as renewals, variations, line extensions, and prompt responses to health authority queries across global jurisdictions. 8.Maintain up-to-date knowledge of global regulatory and provide strategic recommendations based on updated guidelines and country-specific requirements. 9.Ensure regulatory compliance for labeling, artworks, inserts, and packaging as per regional regulations and internal quality standards. 10 .Support and participate in regulatory audits and inspections by ensuring the availability of complete and updated documentation and responses. 11.Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. Preferred candidate profile

1.To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all Latam and CIS , ROW Countries and other country as per company requirements. 2.Responsible for final review of dossier before submission. 3.To coordinate with technical team for documents required for dossier. 4.Responsible to gather data related for dossier through online sources, laboratories, manufactures etc. 5.Reviewing artwork for products as per relevant regulatory authority requirements. 6.To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; 7.Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. 8.Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. 9. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 10. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. .

As a Regulatory Affairs Specialist, you will be responsible for the following tasks: Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil, and ROW market. This includes ensuring compliance with the specific requirements of each regulatory body. Handling the preparation of query responses for drug substances in both highly regulated and less regulated markets, catering to the needs of diverse customers. Creating applicant parts and closed parts for submission to different regulatory authorities on behalf of various clients. Managing the annual updates and amendments of drug master files for the US through ESG, ASMF via CESP, and KDMF via MFDS Korea to maintain regulatory compliance. Coordinating the preparation and submission of CEP (Certificate of Suitability of Monographs of the European Pharmacopoeia) applications and responses to the European Directorate for the Quality of Medicines (EDQM) via CESP. Preparing CEP Letters of Access (LOAs) and declarations for customers and regulatory authorities as required. Conducting research to collect and evaluate scientific data for regulatory assessments and compiling the necessary documentation for submissions to authorities and clients.,

Job Summary: The Team Leader Finance - Reporting will be responsible for end-to-end financial and regulatory reporting related to GIFT City financial books of the life insurance business. This includes timely closure of Gift city books, OPEX booking, GL reconciliation, and ensuring compliance with Statutory regulations. The role involves working closely with cross-functional teams to support business performance reporting, financial control, and regulatory submissions Key Responsibilities: Prepare and file all statutory returns in line with GIFT City regulations. Ensure adherence to deadlines, completeness and compliance in regulatory submissions. Monitor and track operational expenses (OPEX). Ensure timely and accurate month-end and year-end GL closure for GIFT City operations. Perform account-level reconciliations and resolve discrepancies. Maintain accurate financial records specific to GIFT City operations. Ensure compliance with IFSC accounting guidelines and support internal/external audits. Prepare monthly MIS and variance analysis reports. Assist in budgeting, forecasting, and tracking key financial metrics. Automate repetitive reporting processes using Excel VBA or Power BI. Design and implement SOPs for routine Gift City processes and reporting. Coordinate with auditors and provide necessary schedules and documentation. Ensure adherence to internal financial controls and company policies. Collaborate with Finance, IT, Underwriting, Operations, and Compliance etc. teams. Present periodic financial and operational insights to senior management including monthly/quarterly/annual results and reasoning for the same. Skills Required: Knowledge of insurance accounting and financial reporting frameworks. Expertise in GL closure, OPEX tracking, and financial reconciliations. Proficiency in MS Excel, and financial systems (e.g., SAP, Oracle or similar ERP). Familiarity with IRDAI, SEBI, GIFT City / IFSC and SEZ regulatory requirements. Strong analytical, problem-solving, and interpersonal skills.

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as delivering all regulatory milestones for higher complexity products. You will also be accountable for leading the development and review of the CMC Regulatory Strategy Document for projects of increasing complexity. In addition, you will be required to support new technology development within the company and demonstrate an unwavering focus on compliance in all activities. Your technical skills should include expertise in the preparation and review of dossiers, response to queries, and communication with agencies for markets like the US and EU. Furthermore, you should have proven experience in critically reviewing scientific information and possess superior oral and written communication skills in multicultural settings. The ideal candidate for this role will have demonstrated leadership skills, including the ability to generate innovative solutions to complex regulatory problems and effectively work with key stakeholders. You should also exhibit flexibility in responding to changing priorities and possess effective leadership, communication, interpersonal, and negotiating skills. Additionally, you should have good inter-personal skills with the ability to direct multi-departmental functions. This role requires a seasoned professional who is proficient in English, with additional language skills considered a plus. A minimum educational requirement of M-Pharm in pharmaceutical sciences is essential for this position. Lastly, you may be required to manage or mentor junior team members as part of your responsibilities.,

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU. Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

As an intern at Noccarc Robotics, your day-to-day responsibilities will involve conducting clinical validation tests of ICU ventilators, patient monitors, and other critical care devices in hospital and laboratory settings. You will collaborate with intensivists, respiratory therapists, and ICU staff to assess product performance. Additionally, you will be responsible for designing and executing ex-vivo and in-clinic testing protocols to validate device functionality, accuracy, and safety. Your role will also include collecting, analyzing, and interpreting clinical data to provide insights for product improvements. You will document findings, prepare validation reports, and contribute to regulatory submissions. Identifying and troubleshooting device performance issues will be a key part of your responsibilities, as you provide feedback to the engineering and R&D teams for product refinements. Furthermore, you will assist in developing clinical workflows and best practices for the use of Noccarc devices in ICU settings. Conducting competitor benchmarking studies to ensure Noccarc's products remain at the forefront of respiratory care technology will also be part of your tasks. You will have the opportunity to contribute to articles and blogs on best clinical practices, device usage instructions, various manuals, and journals published by Noccarc. Noccarc Robotics is a rapidly growing hardware and med-tech startup in India that was co-founded by IIT Kanpur graduates. The company emerged as a leading manufacturer of ICU ventilators in India, achieving an 18-20% market share in the country. Noccarc Robotics raised its seed round from the IAN Fund in June 2019 and has been profitable since December 2020, with annual revenues exceeding $11 million. The company prides itself on its team's solution-driven, go-getter attitude, result-oriented work culture, and a talented young team comprising individuals from prestigious institutions such as IITs, IIMs, and NITs. With a workforce of 130 employees, Noccarc Robotics has witnessed exponential revenue growth over the past two years.,

Specialized expertise in Inhaler Products including Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI). Method development, validation, and forced degradation studies specific to inhalation dosage forms. Execution and support of technology transfer for analytical methods related to MDI/DPI. Ensure compliance with Quality Assurance systems and applicable regulatory guidelines (ICH, FDA, EMA). Lead analytical activities for ANDA and NDA projects for respiratory products. Coordinate with cross-functional teams for project planning, documentation , and timely regulatory submissions. Review and preparation of analytical method validation protocols, reports, and supporting documentation for regulatory filings. Active involvement in OOS/OOT investigations, troubleshooting, and CAPA implementation.

Hiring for RA Executive / AM For Pharmaceutical-Formulation Qualification: Bsc/B.PHARMA Experience: 7 to 15 Years CTC: 10.0 LPA Send CV on sdpbharuch@gmail.com sub With : RA Vadodara Free Job Share with your Friends & Colleagues!! Required Candidate profile Join Our WhatsApp Group: https://chat.whatsapp.com/EMLcH2RoVs1AzcbRKmZkjZ Follow Our WhatsApp Channel: https://whatsapp.com/channel/0029VaDwTZoHgZWddec9BL0y

About Zydus Wellness Zydus Wellness, an FMCG leader, develops, manufactures, and markets health and wellness products, integrating healthcare, skincare, and nutrition. Founded in 1988 with Sugar Free, India’s first zero-calorie sugar replacement, it now manages seven global brands, including Complan, Glucon-D, Everyuth, and Nutralite. The company serves over 50 million families and supports more than 90,000 dairy farmers and 2,000 MSMEs. With a focus on research, quality, and innovation, Zydus Wellness operates on core pillars of manufacturing integrity and supply chain efficiency. Headquartered in Ahmedabad and Mumbai, it runs four manufacturing facilities across India and eight co-packing facilities in India, Oman, and New Zealand. Listed on the Bombay and National Stock Exchanges, Zydus Wellness is led by Chairman Dr. Sharvil Patel and CEO Tarun Arora, serving customers in over 25 countries across three continents. S. No Get to know our organization – Click on the below links 1 Company Website 2 Zydus Corporate Park Job Title: Assistant Manager - Food Regulatory Affairs Location: Ahmedabad- ZCP, Gujarat, India Department: Regulatory Affairs Functional Reporting: Manager Regulatory Affairs Administrative Reporting: Manager Regulatory Affairs Job Type: Full-time Role: Responsible for ensuring compliance with all food safety and regulatory requirements for the organization’s products. This role involves supporting the preparation, submission, and maintenance of regulatory documents and licenses, coordinating with internal and external stakeholders, and staying updated with evolving food regulations. The incumbent will play a key role in safeguarding the company’s regulatory standing and facilitating market access for new and existing products Key Responsibilities: Regulatory Compliance Management: Ensure compliance with food safety laws, regulations, and standards (e.g., FSSAI regulations, BIS standards, etc.) in India. Monitor regulatory changes and assess their impact on company operations. Liaise with internal teams (R&D, Quality Assurance, Marketing, Legal) to ensure that new products meet regulatory requirements. FSSAI & Legal Documentation: Assist in obtaining and renewing relevant licenses, registrations, and certifications from regulatory authorities such as FSSAI, LM, and other local bodies. Prepare, review, and maintain regulatory documentation and product dossiers for submission to relevant authorities. Work on product labeling, claims, and packaging to ensure compliance with the Food Safety and Standards Act. Risk Assessment and Management: Evaluate potential risks related to food safety, labeling, and regulatory compliance, and propose corrective measures. Conduct risk analysis on new and existing food products to mitigate any potential non-compliance. 4. Financial Support the cost-effective management of regulatory submissions and compliance-related activities 5. Customer Ensure timely and accurate submissions to regulatory authorities to meet business timelines. Address regulatory queries and facilitate smooth approval processes for product registrations 6. Process Prepare, review, and submit regulatory documents, product dossiers, and compliance reports. Maintain regulatory records, databases, and ensure up-to-date documentation. Monitor and interpret changes in food safety regulations and communicate impact to internal stakeholders. Coordinate with R&D, Quality, and Production teams to ensure compliance of product formulations and labeling with regulatory requirements 7. People Collaborate with cross-functional teams to align regulatory activities with business objectives Develop strong working relationships with external regulatory bodies and industry association Key Deliverables Timely submission and approval of regulatory filings for new and existing products. Maintenance of accurate regulatory documentation and compliance databases. Proactive identification and communication of regulatory changes impacting business operations. Key Requirements: Educational Qualification Master’s degree in Dairy Technology or Dairy Sciences (Preference NDRI- Karnal) Additional certification or training in regulatory affairs is a plus. Experience: 1-3 years of experience in regulatory affairs, specifically related to food(Dairy) regulatory and compliance in India. Experience in preparing and handling regulatory submissions, licenses, and compliance documentation Knowledge of food safety regulations and industry standards in India. Skills and Competencies: In-depth knowledge of FSSAI regulations, food safety laws, and compliance requirements in India. Knowledge of national and international food regulations and standards (e.g., FSSAI, Codex) Expertise in regulatory documentation, labeling compliance, and product registrations Familiarity with food safety systems and quality management practices Strong written and verbal communication skills. Attention to detail with the ability to manage multiple projects simultaneously. Strong analytical and problem-solving skills. Ability to work cross-functionally with internal teams and regulatory authorities. Personal Attributes: Proactive and self-driven with the ability to work independently. Strong organizational skills with the ability to prioritize tasks effectively. Ability to maintain confidentiality and handle sensitive information with discretion. Behavioral Competencies Zydus Neev Behavioural Competency Framework Clear and concise communication skills to convey complex regulatory requirements Strong interpersonal skills to work with cross-functional teams and external authorities Meticulous approach to maintaining regulatory documentation and ensuring compliance

Job Summary: The Regulatory Affairs Manager will oversee all regulatory compliance activities related to the companys nutraceutical products, ensuring that all the marketing practices meet applicable global standards (e.g., FDA (U.S.), EFSA (EU), FSSAI (India) . Key Responsibilities: Regulatory Strategy & Compliance. Develop and implement regulatory strategies for product launches and market expansions. Ensure the certifications are renewed on time and also apply for new certifications in new geographies. Interpret and apply country-specific regulations (FDA/DSHEA, EFSA, FSSAI, etc.) to ensure compliance. Dossier & Documentation Management. Prepare and maintain regulatory submissions, including product dossiers, GRAS documentation, and ingredient justifications. Ensure technical files and records (safety data, clinical support for claims, specifications) are audit-ready. Labelling, Claims & Marketing Review. Review and approve labels, packaging, and marketing materials for regulatory compliance. Evaluate substantiation for health and structure/function claims to ensure legal acceptability. Cross-functional Collaboration Collaborate with R&D, Quality, Marketing, and Legal teams to align product development with regulatory requirements. Provide regulatory support during product lifecycle management and reformulations. Regulatory Liaison Act as the point of contact with national and international regulatory agencies (e.g., FDA, EFSA, FSSAI, TGA). Lead the response to agency inquiries, inspections, or compliance reviews. Training & Risk Management Provide internal training on new regulations and compliance procedures. Identify and mitigate regulatory risks associated with ingredients, claims, or labelling. Required Qualifications: Bachelor's or Master’s degree in Pharmacy, Food Science, Chemistry, Life Sciences, or a related discipline. 5+ years of experience in regulatory affairs in the nutraceutical , dietary supplement , or functional foods sector. Strong knowledge of international regulatory frameworks: FDA/DSHEA (U.S.), EFSA (EU), FSSAI (India) . Familiarity with Codex Alimentarius and GMP guidelines preferred. Excellent written and verbal communication skills. Attention to detail and experience handling complex documentation. Preferred Experience: Experience with digital regulatory platforms or document management systems. Experience interacting directly with regulatory authorities or participating in audits/inspections. Regulatory submissions for new ingredients, import/export regulatory support.

As a Clinical Data Manager at Clinvigilant Research Pvt. Ltd., a company of GSC Group, located onsite in Ahmedabad, you will play a crucial role in managing and overseeing the data collected during clinical trials. With 3 to 6 years of experience in clinical data management or a related field, you will ensure the accuracy, integrity, and compliance of clinical trial data with regulations. Your primary responsibility will be to oversee the collection, management, and quality control of clinical trial data. Working closely with clinical research teams, statisticians, and regulatory authorities, you will ensure that data is accurately recorded, processed, and analyzed for clinical trials. Your role will involve developing, implementing, and maintaining the Data Management Plan (DMP) for clinical trials, ensuring alignment with study protocols, regulatory requirements, and internal standards. Collaborating with clinical and statistical teams, you will design and build electronic data capture (EDC) systems and clinical databases. You will perform user acceptance testing (UAT) to verify the proper functioning of these systems. Additionally, you will oversee the collection and validation of clinical trial data, ensuring accuracy and completeness while maintaining data consistency through thorough reviews of case report forms (CRFs). Your responsibilities will also include implementing and managing data cleaning processes, ensuring data quality control, and resolving data discrepancies promptly. You will prepare and maintain comprehensive documentation related to data management processes, ensuring compliance with Good Clinical Practice (GCP) guidelines, ICH guidelines, FDA regulations, and other applicable regulatory bodies. Effective collaboration and communication with cross-functional teams will be essential, as you will serve as the primary point of contact for data-related queries and provide valuable data insights to stakeholders. Training and mentoring clinical data staff, as well as managing relationships with third-party vendors, will be part of your role. Preferred qualifications for this position include experience working with complex clinical trials, knowledge of regulatory submissions and reporting, and familiarity with statistical programming and data analysis tools. If you possess strong proficiency in clinical data management systems, a solid understanding of regulatory requirements, and excellent problem-solving skills, we encourage you to apply for this full-time, permanent position. The work schedule is Monday to Friday, and relocation to Ahmedabad, Gujarat, is required. The expected start date for this role is 03/01/2022. When applying, please provide your self-rating in English proficiency (beginner/average/professional). A Bachelor's degree and a minimum of 3 years of experience in Clinical Data Management are required for this position.,

As the DM- Regulatory Affairs at Olympus Medical Systems India Private Limited, your primary responsibility will be to oversee Indian regulatory affairs activities related to Gastrointestinal (GI) & Olympus products. You will also be responsible for advising and consulting with stakeholders about compliance with CDSCO, BIS, WPC, and other applicable regulatory bodies. Your role will involve implementing best practices and contributing to both the strategic and operational functions of the regulatory affairs team. Your key responsibilities will include assessing regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. You will evaluate the regulatory environment and provide internal advice throughout the product lifecycle to ensure product compliance. Anticipating regulatory obstacles and emerging issues, you will develop solutions and identify requirements and potential obstacles for market access distribution. Furthermore, you will assist in the development of regulatory strategy, update strategy based upon regulatory changes and evaluate proposed products for regulatory classification and jurisdiction. You will determine requirements for regulatory submission, approval pathways, and compliance activities while providing regulatory information and guidance for product development and planning. In addition, you will compare regulatory outcomes with initial product concepts, negotiate with regulatory authorities, and identify the need for new regulatory procedures. You will help train stakeholders on current and new regulatory requirements, provide regulatory input on global regulatory requirements to product development teams, and advise stakeholders of regulatory requirements for quality, preclinical, and clinical data. You will also be responsible for assessing the acceptability of quality, preclinical, and clinical documents for submission filing, evaluating proposed changes for regulatory filing solutions, and monitoring the progress of the regulatory authority review process. Communication and interaction with regulatory authorities before and during the development and review of regulatory submissions will be crucial aspects of your role. To be considered for this position, you are required to have a qualification of M. Pharma/B Pharma along with a PG Diploma in Drug Regulatory Affairs. The preferred experience includes 12 to 15 years of working experience in a customer-oriented position in an international organization. Proficiency in MS Office, particularly Excel, and fluency in oral and written communication in English are essential. Key competencies for this role include business acumen, customer focus (internal and external), execution excellence, domain expertise, effective communication, developing organizational talent, and team leadership. By applying your expertise and knowledge, you will play a vital role in ensuring regulatory compliance and contributing to the success of Olympus Medical Systems India's regulatory affairs team.,

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into project timelines and deliverables. Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements. Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions. Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed. Participate in internal and external audits and inspections related to regulatory compliance. Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation Qualifications Bachelors degree in a science, pharmacy, or a related field; advanced degree (e.g., Masters, PhD) preferred. Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry. Skills Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams. Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.

As the Statistical Science Director at our organization, you will play a crucial leadership role in advancing the application of statistical science within the pharmaceutical industry. Your extensive experience in statistical methodology, project design, delivery, and interpretation will be instrumental in guiding various stages of product development. Your responsibilities will include leading statistical strategy for projects, contributing to regulatory submissions, and influencing internal governance decisions. The ideal candidate for this role is recognized externally as an expert in statistical methods and possesses the ability to guide complex analyses while mentoring junior staff. Strong cross-functional collaboration skills are essential for success in this position. Your key responsibilities will involve project leadership, where you will lead statistical design and strategic planning for product development across preclinical studies, regulatory strategies, health technology assessments, and commercial applications. You will oversee statistical content development to ensure high-quality study design, documentation, analysis delivery, interpretation, and regulatory submission. Additionally, you will be responsible for quantifying and communicating the benefit-risk profile, value, and uncertainty associated with emerging product data. As the Statistical Science Director, you will provide leadership across global teams, direct the work performed by internal statisticians and external partners, and manage partnerships with CROs to ensure timely and high-quality deliverables. Staying current with statistical methodologies and promoting the adoption of innovative approaches will also be a key part of your role. You will present statistical strategies and recommendations at internal governance forums and mentor and coach statisticians to contribute to their technical development and training. In terms of technical and methodological leadership, you will be expected to demonstrate deep knowledge of technical and regulatory requirements in pharmaceutical and healthcare settings. You will lead the implementation of novel statistical methodologies into applied practice and contribute to or lead regulatory interactions and submissions from a statistical perspective. Building and maintaining strong collaborative relationships through excellent communication will be essential. Your goal will be to achieve national or international recognition as a statistical expert through speaking engagements, publications, and external collaborations, serving in a technical leadership capacity to guide the direction and delivery of work across teams. To qualify for this role, you should have an MSc or PhD in Statistics, Mathematics with a strong statistical component, or an equivalent degree. You must have proven ability to lead statistical activities independently across complex projects and possess exemplary technical and analytical skills with a track record of delivering impactful statistical strategies. A PhD in Statistics or a related discipline is typically required, along with being a recognized expert in statistical methodology and demonstrating leadership in technical areas. Desirable attributes include therapeutic area or disease-specific expertise, exposure to business development activities, project management capabilities, and proficiency in statistical programming languages such as SAS, R, and Python.,

Your main responsibilities as a selected intern will include: Conducting clinical validation tests of ICU ventilators, patient monitors, and other critical care devices in both hospital and laboratory settings. You will collaborate closely with intensivists, respiratory therapists, and ICU staff to evaluate the performance of products. Additionally, you will be responsible for designing and implementing ex-vivo and in-clinic testing protocols to ensure the functionality, accuracy, and safety of devices. You will play a key role in collecting, analyzing, and interpreting clinical data to generate valuable insights for enhancing product improvements. Documenting your findings, preparing validation reports, and contributing to regulatory submissions will be crucial aspects of your role. You will also be expected to identify and troubleshoot any device performance issues and provide constructive feedback to the engineering and Research & Development (R&D) teams for continuous product refinements. Assisting in the development of clinical workflows and best practices for the utilization of Noccarc devices in ICU settings will be an important part of your responsibilities. Moreover, you will be involved in conducting competitor benchmarking studies to ensure that Noccarc's products remain innovative and competitive in the field of respiratory care technology. Your contribution to articles, blogs, and various manuals on best clinical practices, device usage instructions, and journals published by Noccarc will be highly valued. About the Company: Noccarc Robotics is a rapidly growing hardware and med-tech start-up based in India, co-founded by graduates from IIT Kanpur. The company swiftly emerged as a prominent manufacturer of ICU ventilators in India during the early stages of the COVID-19 pandemic in 2020, achieving this feat in less than 90 days. Currently, Noccarc holds a significant market share of 18-20% in the ICU ventilator segment in India. Notably, the company secured its seed funding from the IAN Fund in June 2019 and has been profitable since December 2020, with annual revenues exceeding $11 million. What sets Noccarc apart is its team's proactive approach towards challenges and commitment to delivering effective solutions. The company fosters a result-oriented work culture and boasts a talented young team comprising individuals from prestigious institutions such as IITs, IIMs, NITs, and other renowned colleges. With a workforce of 130 individuals, Noccarc has experienced remarkable growth in revenue over the past two years, establishing itself as a profitable entity in the industry.,

As a Polymorph Screening Scientist at Morepen Proprietary Drug Research Pvt Ltd. (MPDRPL), your primary responsibility will be to lead the screening and selection of solid forms for drug candidates. You will play a crucial role in improving the physicochemical properties of active pharmaceutical ingredients (APIs) by overseeing polymorph screening activities. It is essential to identify the most stable and bioavailable forms of drug substances for regulatory submissions. Collaborating with cross-functional teams, you will mentor junior scientists and drive advancements in solid-state drug discovery. Your key responsibilities will include overseeing the screening of potential polymorphs, solvates, and hydrates for APIs, interpreting and analyzing solid-state data, scaling up identified novel polymorphs, collaborating with various teams to align polymorph selection with drug formulation strategies, preparing regulatory-compliant data for filings, troubleshooting any issues related to polymorph stability, and ensuring accurate documentation and reporting of experimental protocols and findings. The deliverables expected from you include the identification and characterization of stable polymorphs and crystal forms for drug candidates, detailed screening reports, regulatory-compliant data for solid-state forms, and methodologies for high-throughput screening, scaleup, and solid-state characterization. To qualify for this role, you should hold a Ph.D. in Pharmaceutical Sciences, Solid state Chemistry, Chemistry, or a related field, with a focus on solid-state chemistry or materials science. Alternatively, a Master's degree with equivalent experience will be considered. You should have a minimum of 6+ years of industry experience in solid-state chemistry, polymorph screening, or pharmaceutical development and proven expertise in solid-state characterization techniques and polymorph screening methods. Proficiency in solid-state characterization methods, high-throughput screening techniques, and knowledge of computational techniques for polymorph prediction are essential technical skills required for this role. In addition to technical skills, you should possess excellent problem-solving, troubleshooting, and decision-making skills. Effective communication skills, both written and verbal, are crucial for presenting complex data to diverse audiences. Being detail-oriented with strong organizational and documentation skills will contribute to your success in this role at MPDRPL.,